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Labeling and Packaging

Identify errors before your products reach the market.

Minimize errors and avoid costly revisions

Improving labeling and packaging approaches is essential to reducing errors and enhancing healthcare accuracy. Med Safety Board, powered by ECRI and ISMP, helps the pharmaceutical industry and 503B outsourcing companies optimize product labels and packaging to ensure safe use. Though our experts focus on identifying potential labeling errors before products reach the market, helping you save money and time, they can also help identify error-prone labeling and packaging at any phase of the product lifecycle, including post-approval.

Our Approach

Every labeling and packaging design or review project begins with a search of similar product reports submitted to the ISMP National Medication Errors Reporting Program (ISMP MERP). Med Safety Board experts analyze these reports to identify potential errors and strategies to avoid them, ensuring labels meet current standards, guidelines, and regulatory requirements from organizations like the USP, FDA, Health Canada, and EMA, when applicable.

Project considerations include:

Overall appearance and readability of the labels, including placement on the actual container

Placement and prominence of critical information

Readability and understanding of key information needed by the end user to properly use the medication

Use of potentially confusing terminology, abbreviations, symbols/icons, and dose designations

Size and prominence of product logo or corporate dress

Readability, clarity, and/or positioning of expiration dates, lot numbers, and barcodes

Potential for look-alike confusion with other similar products in a company’s line

Label and packaging match the dosing of the product

Packaging is appropriate for the route of administration

Why It Matters

Labeling and packaging-related medication errors are among the most frequently reported to the ISMP National Medication Errors Reporting Program (ISMP MERP). Issues like visual label similarities, missing critical information, and error-prone packaging have contributed to serious medication errors and patient harm. Addressing these problems is crucial to improving medication safety.

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